RA: Viable Alternative for bDMARD-Refractory Patients Identified
In patients with active rheumatoid arthritis (RA) that is refractory to biologic disease-modifying anti-rheumatic drugs (bDMARDs), the selective Janus kinase 1 (JAK1) inhibitor upadacitinib is likely a viable treatment option.
These findings arose from a phase 3 study of 499 patients aged 18 years or older with RA across 153 sites in 26 countries.
_____________________________________________________________________________
YOU MAY ALSO LIKE:
Emerging Treatments for Rheumatoid Arthritis: Update
Rheumatoid Arthritis Remission Less Likely in Overweight Patients
_____________________________________________________________________________
All patients included in the analysis had active disease with a mean disease duration of 13.2 years, had previous inadequate response or intolerance to bDMARDs, and were treated concomitantly with background conventional synthetic DMARDs (csDMARDs).
Patients were randomly assigned to treatment with once-daily, oral extended release 15-mg or 30-mg upadacitinib or placebo for 12 weeks, followed by 15-mg or 30-mg upadacitinib from week 12 onwards.
Results of the study showed that 106 (65%) of 164 patients in the 15-mg upadacitinib group and 93 (56%) of 165 patients in the 30-mg upadacitinib group achieved a 20% improvement in American College of Rheumatology criteria at week 12 compared with 48 (28%) of 169 placebo-treated patients.
Furthermore, 71 (43%) patients treated with 15-mg upadacitinib and 70 (42%) patients treated with 30-mg upadacitinib achieved a 28-joint disease activity score using C-reactive protein of 3.2 or less at week 12 compared with 24 (14%) patients receiving placebo.
The most commonly reported adverse events at week 12 were upper respiratory tract infection, nasopharyngitis, urinary tract infection, and worsening of RA. Each of these events occurred in at least 5% of patients in any treatment group.
“Both doses of upadacitinib led to rapid and significant improvements compared with placebo over 12 weeks in patients with refractory rheumatoid arthritis,” the researchers concluded.
—Christina Vogt
Reference:
Genovese MC, Fleischmann R, Combe B, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial [Published online June 13, 2018]. Lancet. https://doi.org/10.1016/S0140-6736(18)31116-4